An Equal Opportunity Provider and Employer

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-11

TO: Veterinary Services Leadership Team 

Directors, Center for Veterinary Biologics 

Biologics Licensees, Permittees, and Applicants

FROM: Byron E. Rippke

Director

SUBJECT: Facility Documents Processing Changes – Pilot Project

I. PURPOSE

The Center for Veterinary Biologics (CVB) has evaluated the processing of facility 

document submissions as a part of a business process improvement project. The 

proposed outcome has been to reduce the CVB resources needed to process 

incoming facility document submissions and to reduce the time to respond to these 

submissions, while ensuring that the review performed by CVB on each facility 

document submission is thorough and complete. 

II. BACKGROUND

Baseline data have been collected as a part of this business process improvement to 

provide benchmark measurements for the revised process. The revision of 

Veterinary Services (VS) Memorandum 800.78, Preparation and Submission of 

Facilities Documents, dated August 18, 2017, and the development of a single-page 

form for submission and processing facility documents are expected to increase 

both the quality and consistency of facility document submissions and result in a 

decreased response time by the CVB for each submission. 

The CVB review and processing of facility documents will focus on ensuring 

licensees and permittees have provided sufficient information, especially regarding 

the function of each room and the precautions taken to assure product quality and 

safety. 

III. ACTION

The CVB will conduct a pilot project using revised VS Memorandum 800.78 and 

the draft Facility Document Submission Form (FDS) and encourages all licensees 

and permittees to participate. 

The CVB-Inspection and Compliance has developed an FDS that is currently under 

review by the Office of Management and Budget. A draft of the FDS and 

instructions for use are attached to this Notice and should be used during the pilot 

project. 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 17-11

Page 2

An Equal Opportunity Provider and Employer

CVB will also be instituting a practice of auditing back the submission if the facility 

documents are incomplete and do not meet the basic facility requirements as listed in 

title 9, Code of Federal Regulations (9 CFR), part 108. Examples of this include, but are 

not limited to, no signature of the responsible official on the plot plan or blueprint or no 

compass points shown. 

The CVB response to the facility document submission will be marked on the bottom 

portion of the FDS and returned to the establishment with the facility documents. 

Responses will be one of the following:

[A] Documents Filed indicates the submission has been accepted with no revisions 

necessary. 

[B] Documents Filed, Revisions Requested indicates the submission has been accepted 

with changes required to be made at the next revision. A listing of issues with the 

applicable 9 CFR reference will be sent back to provide guidance. 

[C] Documents Returned indicates the submission is insufficient for filing. A listing of 

issues with the applicable 9 CFR reference will be sent back to provide guidance. But 

note, this listing may be incomplete as the review will cease if several items are not in 

compliance with the regulations. This would be an indication the quality review at the 

establishment was not adequate. This action would also be used for submissions that are 

audited back as incomplete. 

IV. IMPLEMENTATION/APPLICABILITY

The pilot project will be in effect for 2 months upon publication of this Notice for all 

licensees and permittees (including both quarantine sites and foreign manufacturing 

sites). It would also be beneficial for establishments in the pre-licensing phase of 

licensure or permit approval to use this process. During the 2-month pilot project, the 

CVB will be evaluating the revised process and gathering data. Updates to the process 

may be implemented at the end of the pilot project.